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United Kingdom — medical device regulations

Authority：MHRA · Updated 2026-09-09

36regulations and guidance
271update records

Regulations and guidance

TypeNumberTitleStatus
Act2020 c. 29European Union (Future Relationship) Act 2020in_force
Act2021 c. 3Medicines and Medical Devices Act 2021in_force
RegulationS.I. 2002/618The Medical Devices Regulations 2002in_force
RegulationS.I. 2002/618 PART 4APost-market surveillance requirementsin_force
RegulationS.I. 2002/618 PART IIntroductory Provisions Relating to all Medical Devicesin_force
RegulationS.I. 2002/618 PART IIGeneral Medical Devicesin_force
RegulationS.I. 2002/618 PART IVIn Vitro Diagnostic Medical Devicesin_force
RegulationS.I. 2002/618 PART VIFees charged by the Secretary of Statein_force
RegulationS.I. 2003/1400The Enterprise Act 2002 (Part 9 Restrictions on Disclosure of Information) (Amendment and Specification) Order 2003in_force
RegulationS.I. 2003/1697The Medical Devices (Amendment) Regulations 2003in_force
RegulationS.I. 2005/2759The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005in_force
RegulationS.I. 2005/2909The Medical Devices (Amendment) Regulations 2005in_force
RegulationS.I. 2007/400The Medical Devices (Amendment) Regulations 2007in_force
RegulationS.I. 2007/803The Medicines for Human Use and Medical Devices (Fees Amendments) (No.2) Regulations 2007in_force
RegulationS.I. 2008/2936The Medical Devices (Amendment) Regulations 2008in_force
RegulationS.I. 2010/557The Medical Devices (Fees Amendment) Regulations 2010in_force
RegulationS.I. 2011/1043The Treaty of Lisbon (Changes in Terminology) Order 2011in_force
RegulationS.I. 2012/1426The Medical Devices (Amendment) Regulations 2012in_force
RegulationS.I. 2013/2327The Medical Devices (Amendment) Regulations 2013in_force
RegulationS.I. 2013/525The Medical Devices (Fees Amendment) Regulations 2013in_force
RegulationS.I. 2017/207The Medical Devices (Fees Amendment) Regulations 2017in_force
RegulationS.I. 2019/1385The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019in_force
RegulationS.I. 2019/791The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019in_force
RegulationS.I. 2020/1478The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020in_force
RegulationS.I. 2020/1662The European Union (Future Relationship) Act 2020 (Commencement No. 1) Regulations 2020in_force
RegulationS.I. 2021/610The Medicines and Medical Devices Act 2021 (Commencement No. 1 and Transitional and Savings Provision) Regulations 2021in_force
RegulationS.I. 2021/873The Medical Devices (Amendment) (EU Exit) Regulations 2021in_force
RegulationS.I. 2021/905The Medical Devices (Northern Ireland Protocol) Regulations 2021in_force
RegulationS.I. 2021/910The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021in_force
RegulationS.I. 2023/377The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023in_force
RegulationS.I. 2023/627The Medical Devices (Amendment) (Great Britain) Regulations 2023in_force
RegulationS.I. 2024/1368The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024in_force
RegulationS.I. 2024/221The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024in_force
RegulationS.I. 2025/591The Medical Devices (Amendment) (Great Britain) Regulations 2025in_force
RegulationS.I. 2025/749The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025in_force
RegulationS.I. 2026/197The Medical Devices (Fees Amendment) Regulations 2026in_force

Regulatory updates

DateTypeTitle
2026-09-03newField Safety Notices: 24 to 28 August 2026
2026-09-02newFilters should be used during the administration of Parenteral Nutrition for patients in all care settings DSI/2026/011
2026-09-01newMHRA regulatory reform amendments tabled in Government’s Health Bill
2026-08-28newMedical devices given exceptional use authorisations
2026-08-26newIncreased risk of wear and corrosion identified with certain cobalt chrome modular neck hip replacements
2026-08-26newCobalt-chrome modular neck hip replacements: risk of metal-wear effects and revision surgery (DSI/2026/010)
2026-08-25newMHRA Safety Roundup: August 2026
2026-08-24newNGPod pH testing device: quarantine and dispose of all devices (DSI/2026/009)
2026-08-24newField Safety Notices: 17 to 21 August 2026
2026-08-20newRectal catheters sold for personal use (gas and colic relievers): Do not use in infants, including for the treatment of colic, gas-related discomfort or constipation (DSI/2026/008)
2026-08-18newField Safety Notices: 13 to 17 July 2026
2026-08-18newField Safety Notices: 10 to 14 August 2026
2026-08-17newNational Patient Safety Alert: ResMed Astral 100 and 150 Ventilators: Potential for Patient Harm due to Unexpected Interruption of Ventilation Therapy (NatPSA/2026/004/MHRA)
2026-08-13guidanceMagnetic resonance imaging equipment in clinical use: safety guidelines
2026-08-13guidanceCOVID-19 test approval: how to apply
2026-08-12guidanceClinical investigations for medical devices
2026-08-11newField Safety Notices: 3 to 7 August 2026
2026-08-10newMHRA advises quarantine of medical devices supplied without appropriate conformity markings
2026-08-10newDevices supplied without valid UKCA/CE conformity markings or certification: remove from use and place in quarantine (DSI/2026/007)
2026-08-06guidanceClinical investigations: compiling a submission
2026-08-06newBelzer UW® Cold Storage Solution and Belzer MPS® (UW Machine Perfusion Solution): manufactured by Carnamedica (UKRP: Bridge to Life): Updated advice on the contamination of fluid DSI/2026/006 (update to DSI/2023/005)
2026-08-04newField Safety Notices: 27 to 31 July 2026
2026-08-04newDräger Atlan Anaesthesia workstations: risk of ventilator failure (DSI/2026/005)
2026-07-30newPioneering AI health innovations regulatory sandbox launched
2026-07-30newMHRA Safety Roundup: July 2026
2026-07-30guidanceLondon Region I MHRA Regulatory Sandbox: call for expressions of interest
2026-07-29newMHRA clarifies regulatory status of ambient voice technologies used in the NHS
2026-07-29newField Safety Notices: 29 June to 03 July 2026
2026-07-29guidanceDigital mental health technology: qualification and classification
2026-07-29newBeat the heat: MHRA urges people to take extra care with medical devices this summer
2026-07-29guidanceAmbient voice technology-enabled products
2026-07-28newField Safety Notices: 20 to 24 July 2026
2026-07-27guidanceAI Airlock Sandbox Phase 2 Programme Report
2026-07-23guidanceMedical devices that need a clinical investigation
2026-07-23guidanceClinical investigations in Great Britain
2026-07-23guidanceApproving clinical investigations
2026-07-20guidanceRegister medical devices to place on the market
2026-07-20guidanceMedical devices: legal requirements for specific medical products
2026-07-20guidanceCustom-made medical devices in Great Britain
2026-07-17guidanceMedical devices: list of UK approved bodies
2026-07-14guidanceIn vitro diagnostic point-of-care test devices
2026-07-14newField Safety Notices: 6 to 10 July 2026
2026-07-01newMHRA secures convictions after a decade-long investigation into falsely marked baby-feeding devices
2026-06-30newMHRA Safety Roundup: June 2026
2026-06-30newField Safety Notices: 22 to 26 June 2026
2026-06-29guidanceMHRA Horizon Scanning and Innovation case studies
2026-06-29guidanceBorderline products: medical devices and other products
2026-06-24guidanceCOVID-19 test validation approved products
2026-06-23newField Safety Notices: 15 to 19 June 2026
2026-06-15newField Safety Notices: 8 -12 June 2026
2026-06-11guidanceRegulation of medical devices in Northern Ireland
2026-06-11guidanceMedical devices: ask for a regulatory advice meeting from the MHRA
2026-06-09guidanceAI Airlock: the regulatory sandbox for AIaMD
2026-06-09guidanceAI Airlock Simulation Workshops
2026-06-08newField Safety Notices: 1-5 June 2026
2026-06-05newField Safety Notices: 18 -22 May 2026
2026-06-02newField Safety Notices: 25 to 29 May 2026
2026-05-28newMHRA Safety Roundup: May 2026
2026-05-27newAllurion Gastric Balloon: Updated safety information due to the risks of gastric outlet obstruction, small bowel obstruction and gastric perforation (DSI/2026/004)
2026-05-22newKimal Procedure Packs containing recalled components: Namic Angiographic Syringe with the risk of syringe disconnection; Namic Manifolds with the risk of foreign particulates. Important guidance for use in urgent procedures where there are no alternatives. (DSI/2026/002)

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